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BioequivalencePhase 1NCT06124573

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.

A Phase 1 study testing Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet in people with Bioequivalence and Diabetes Mellitus, Type 2, run by Galenicum Health at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose administration under fed conditions. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Bioequivalence, Diabetes Mellitus, Type 2
What is being tested?
Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteMexico
Study dates
7 Nov 2022to 21 Nov 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male and female subjects aged ≥ 18 and ≤ 55 years.
  • Subjects is a non-or ex-smoker (An ex-smoker is defined as someone who completely stopped smoking for at least 6 months before screening).
  • With a weight ≥ 50.00 kg.
  • With a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 27.0 kg/m2.
  • Found healthy according to the clinical laboratory results and physical examination (performed within 28 days prior to the dosing on period 1).
  • Have a normal 12-lead ECG and vital signs.
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  • Have laboratory test results within the laboratory's stated normal range; if not within this range, they must lack of clinical significance as judged by the PI or responsible physician.
  • If the subject of the study is female and childbearing potential / fertile (a woman is considered fertile from first menstruation and until she becomes postmenopausal, or permanently sterile), and agrees to use ANYONE of the following forms of effective contraception / birth control (but not limited to) from the time of enrollment into the study and until at least 7 days after the last study drug administration, as judged by the PI considering the pharmacology of IP(s):
  • Established use of oral, transdermal, injected or subdermal implanted hormonal methods.
  • Intrauterine device (IUD or intrauterine system (IUS). i. Barrier methods: e.g., diaphragm, cervical cap or condom (male or female condom).
  • Spermicidal: e.g., spermicidal foam, sponges or film. k. Undergone bilateral tubectomy. l. Accept to remain abstinent: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception] OR Women who are postmenopausal (defined as female with no menses at least for the last 12 months without any medical cause) or permanently sterilized (e.g., undergone hysterectomy, bilateral salpingectomy or oophorectomy at least for the last 3 months).
  • If the subject of the study is male, he must be willing to use ANYONE of the following forms of effective contraception / birth control (but not limited to) and willing not to donate sperm; from the time of enrollment into the study and until at least 7 days after the last study drug administration, as judged by the PI; d. Willing to remain abstinent: When this is in line with the preferred and usual lifestyle of the subject.
  • Willing to use a male condom. f. Male sterilization (men who have had vasectomy, at least 3 months previous to drug administration).
  • Subject able to communicate effectively and voluntarily agreed to participate in this study by signing written informed consent after being informed sufficiently about study aspects like objectives, study procedures, characteristics of the investigational drug, expected adverse events.
  • Subject willing to adhere to protocol requirements as evidenced by signing the informed consent form approved by the REC \& RC.

Who cannot join

  • Have any history of allergy or hypersensitivity to sitagliptin and metformin or to any of its metabolites/derivatives or related drugs or excipients.
  • Have a positive test result for HBs Ag or HCV Ab or HIV antibodies (types 1 and 2) or VDRL.
  • The study drug is contraindicated for medical reasons for the subject as per protocol section 3.7.
  • Have any history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, neurological or psychiatric disease or disorder (e.g., subjects with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute confusional states) as judged by the PI considering the pharmacology of IP(s).
  • Presence of gastrointestinal, hepatic or kidney disease, or surgery or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
  • Or Subjects with a history of gastrointestinal disorder or surgery which may affect the absorption of investigational drug.
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  • Have history or presence of Corona Virus Disease (COVID-19) during the last 30 days prior to dosing of period 1.
  • Or Have history of vaccination (any dose) for COVID-19 during the last 14 days prior to dosing of period 1.
  • Or Any planned vaccination for COVID-19 during the study period.
  • Have history or presence of cancer.
  • Have a history or evidence of drug abuse or alcohol abuse.
  • Have a history of smoking cigarettes during the last 6 months prior to screening.
  • Have any history of gastrointestinal ulcers / bleeding.
  • Have difficulty in swallowing solid medications such as tablet.
  • Have a history or evidence of difficulty with donating blood.
  • Have clinically significant abnormal laboratory tests results.
  • Have a systolic blood pressure < 90 or > 140 mmHg or diastolic blood pressure is < 60 or > 90 mmHg
  • Have a pulse rate less than 60 bpm or greater than 100 bpm (lower range will be accepted up to 45 bpm in case of athlete).
  • Have used any prescribed medication during the last 14 days preceding the first dosing, or use OTC, herbal products during the last 7 days or use medicinal enzyme inhibitors / inducers during 30 days preceding the first dosing.
  • Have participated in a drug research study the last 3 months or donated blood within the last 3 months.
  • Have a positive result for the alcohol test (breath / saliva) or drugs of abuse test [Cannabinoids (Marijuana/Tetrahydrocannabinol-THC), Cocaine, Opiates/Morphine, Amphetamine, Methamphetamine and Benzodiazepines] performed during screening.
  • Female subject, who is currently breast feeding or a who is pregnant or who is likely to become pregnant during the study.
  • Female subject has a positive pregnancy test result.
  • Unwillingness or inability to comply with the instructions on the restrictions and/or study procedures described in this Protocol.
  • If the PI considers, for any reason, that the volunteer is not a suitable candidate to receive the study drug.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Avant Santé Research Center S.A. de C.V.

    San Pedro Garza García, Nuevo León, 66260

Other trials in Mexico

About this study

Official title: An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) of Galenicum Health S.L.U., Spain With That of JANUMET® XR (Sitagliptin Phosphate / Metformin Hydrochloride) Extended-release Coated Tablets 100 mg / 1000 mg (FDC) of Merck Sharp & Dohme Pharmaceuticals Ltd., Brasil in Healthy Adult Male and Female Subjects Under Fed Conditions.

The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose administration under fed conditions.

Being tested
Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tabletDrug

    The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet

Study groups in NCT06124573
Study groupRoleWhat they receive
Reference groupExperimentalAfter an overnight fasting of at least 10.00 hours prior to start of high-fat and high-calorie (approximately 800 to 1000 calories) breakfast, subjects were administered a single-dose of the reference product along with 250 mL of 20% glucose in water solution at room temperature.
Receives: Drug: Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
Test groupExperimentalAfter an overnight fasting of at least 10.00 hours prior to start of high-fat and high-calorie (approximately 800 to 1000 calories) breakfast, subjects were administered a single-dose of the test product along with 250 mL of 20% glucose in water solution at room temperature.
Receives: Drug: Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plasma Concentration (Cmax)

    Evaluation of Peak Plasma Concentration (Cmax)

    Measured: 48 hours

  2. Area under the plasma concentration versus time curve (AUC)0-t

    Evaluation of Area Under Plasma Concentration-Time Curve from Time Zero to the Last Measurable Concentration

    Measured: 48 hours

  3. Area under the plasma concentration versus time curve (AUC) 0-inf (Metformin only)

    Area Under Plasma Concentration-Time Curve from Time 0 to Infinite

    Measured: 48 hours

Secondary outcomes (1)

  1. Number of participants with adverse events (AEs)

    To evaluate the safety and tolerability of a single oral dose of Sitagliptin /Metformin extended-release film coated tablets 100 mg /1000 mg (FDC) under fed conditions

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2023
  2. Study start7 Nov 2022
  3. Primary completion21 Nov 2022
  4. Study completion21 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06124573
Sponsor's protocol ID
AS/CJ/MAR-22/0011
Status last verified
Nov 2023
First submitted
2 Nov 2023
Last updated
9 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet in people with Bioequivalence and Diabetes Mellitus, Type 2, run by Galenicum Health at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06124573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.

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